Comparison · NCT04599972-92e15938
CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. Trial comparisons, record NCT04599972-92e15938. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04599972-92e15938
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.416 | 0.341 | 0.495 | wilson | |
| Risk in group 2 | 0.213 | 0.155 | 0.286 | wilson | |
| Risk difference, group 1 minus group 2 | 0.202 | 0.0982 | 0.3 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.95 | 1.36 | 2.79 | log | |
| Odds ratio, group 1 over group 2 | 2.62 | 1.58 | 4.35 | log | |
| Number needed to treat, for one more participant with the outcome on CSF-1 than on Vehicle | 4.94 | 3.33 | 10.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CSF-1 | One drop bilaterally twice daily for approximately 2 weeks.~CSF-1: One drop bilaterally twice daily for approximately 2 weeks. | 64 | 154 | OG000 |
| Group 2 | Vehicle | One drop bilaterally twice daily for approximately 2 weeks.~Vehicle: One drop bilaterally twice daily for approximately 2 weeks. | 32 | 150 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
- Description
The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment.~A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
- Time frame
- Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
- Population
- Full analysis set (FAS): included all randomized subjects who received at least 1 dose of the study drug. Subjects in the FAS were analyzed as randomized.
Source ClinicalTrials.gov
Trial
- Title
- An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
- NCT number
- NCT04599972
- Phases
- PHASE3
- Conditions
- Presbyopia
- Interventions
- CSF-1, Vehicle
- Lead sponsor
- Orasis Pharmaceuticals Ltd.
- Results first posted
- 2023-11-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04599972?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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